Regulatory Affairs: |
Completing your clinical trial on time and on budget requires proactive regulatory management and guidance. Well versed in domestic and international regulations, our experienced professionals have developed strict audit processes that ensure regulatory compliance throughout your study.
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| Proactive guidance |
Multiple regulatory questions may arise during the course of your trial. Our Regulatory Affairs staff follows the constantly evolving regulatory environment to anticipate problems and avoid costly delays. From the initial planning of a study to submission, this proactive approach to regulatory compliance helps to assure your marketing application, labeling change, or product improvement is favorably received. |
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| Tailored, expert assistance |
| Our regulatory staff are experienced and specifically trained for clinical trials work. Customized contingency plans designed to handle even the most complex regulatory issues provide positive benefits to your schedule. |
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| Continuous monitoring of regulatory activities
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Proactive planning for new and changing regulations ensures that your study remains compliant and progresses forward, without unexpected delays. Monitoring government proceedings and regulatory publications of both domestic and global regulatory bodies enables us to stay current with new mandates — positioning your study to meet regulatory requirements. |
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| Strict audit processes
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| Continuous quality improvements in processes and capabilities are a direct result of the robust internal review system. These evaluations verify that systems and procedures are current, compliant, and always prepared for external audits. A fully developed, external audit process smoothly facilitates sponsor and vendor audits and regulatory inspections.
Regulatory inspections have many nuances and require the leadership of a highly experienced staff that is able to manage the inspection and guide auditors appropriately. Ensuring rules are followed and inspections can be executed at any time protects your interests.
All vendors supplying critical goods or services to your clinical trial are included in our internal audit process. This ensures that any suppliers for your study, either direct or indirect, meet all GXP requirements. Beyond ensuring only regulatory compliance, vendors are also monitored for an effective disaster recovery plan, protecting you from the loss of critical services from uncontrollable events. Your clinical trial runs smoothly and reliably, is on time and on budget.
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